Concert Pharmaceuticals has announced a second open label clinical trial into a form of its novel oral treatment for Alopecia Areata, CTP-543 is due to start soon.
This will concentrate on a one-a-day 24mg dose of CTP-543 and will compare results to 12mg twice-daily doses, taken by separate, randomized groups over a 24 week period.
Each of the 60 patients taking part across the USA and Canada will have a confirmed diagnosis of hair loss from Alopecia Areata, Alopecia Totalis or Alopecia Universalis.
These are the key forms of the autoimmune disease Alopecia Areata, which presents as patchy hair loss to the scalp only (Alopecia Areata), total baldness of the head, often including a loss of eyelashes, eyebrows and facial hair (Alopecia Totalis), and complete hairlessness from head to toe (Alopecia Universalis).
Whilst not exactly a JAK inhibitor itself - the suite of drugs currently leading the race to produce the first authorised, MHRA-licensed and FDA-cleared treatment for all forms of Alopecia Areata - CTP-543 is a deuterium modified version of the Janus kinase 1 and 2 inhibitor, ruxolitinib (brand name, Jakafi).
This new trial - which is currently estimated to complete in April 2020 - has been designed to complement Concert's first open label trial of CTP-543. Findings should help researchers to determine the drug's optimal dosing, providing the basis of doses to be tested further in additional clinical trials.
The first study, which began in March 2019 and is due to complete later in the year, involves participants receiving oral CTP-543 doses of either 8 mg twice per day or 16 mg once each day, for a total of 24 weeks.
Both trials will compare patients' baseline and 24 week-mark Severity of Alopecia Tool (SALT) scores in order to determine the drug's - and dose's - efficacy.
“Our aim is to optimize the dosing regimen for CTP-543, so that we can best meet the needs of patients with this autoimmune disease for which there are currently no FDA-approved treatments,” said James V. Cassella, Ph.D., Chief Development Officer of Concert Pharmaceuticals, via a company press release.
The most recent update as to how the current CTP-543 trials are going, was provided at the March 2019 American Academy of Dermatology (AAD) Annual Meeting, where promising interim results were disclosed from an ongoing Phase 2 trial.
Concert Pharmaceuticals' CTP-543 has received Fast Track designation from the FDA, along with two other companies also developing potential hair loss solutions - oral and/or topical - to address mild to severe Alopecia Areata.
Due to the significant emotional and psychological effects these various forms of sudden hair fall can cause, and the fact no FDA-approved - nor MHRA-licensed - hairloss treatment for these specific conditions yet exists, the FDA is hoping to help speed up the process for developing treatments by working closely with the most promising candidates.
The earliest likely release date for any of these novel hair loss solutions is estimated to be 2021-22.
Adults with more extensive baldness, or children with any form of Alopecia, are advised to contact their GP or dermatologist as a first port of call. Hair loss charities can also provide invaluable help in the form of free wigs, contacts for suppliers and local or online peer support groups.
However, hopefully, we are now closer than ever to there being a realistic treatment option for those who have lost their hair to conditions as severe as Alopecia Universalis, and would love to have it back again.
UPDATE: On 5th June 2019 it was announced by Concert Pharmaceuticals that the company had completed enrolment for this trial and topline data from this study is expected between October and December 2019.
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